For those of you following this blog, you will be familiar with our assessment of the recent decisions from the Supreme court in Mayo Collaborative Services v. Prometheus Laboratories and Alice Corp. v. CLS Bank International. These cases concerned what types of inventions qualify for patent protection under 35 U.S.C. 101, the statute governing patent eligibility. The cases were decided by the Supreme Court in 2012 and 2014, respectively, and both resulted in the invalidation of the patents involved. The first of these cases, Mayo, involved a method of administering a drug, gathering data on how the patient was responding to that drug, and deciding whether or not to alter dosage based on that information. This was determined to be a manipulation of natural laws using data and methods known to persons skilled in the art. Alice dealt with software for financial transactions, which the Court ruled to be an “abstract idea.”

Mayo and Alice ...interpretation, but too far?

So why is it that these cases have become points of contention in the field of patent law? Simply put, these Supreme Court decisions offer precedent which is at best unhelpful for attorneys and courts, and at worst seriously concerning for patent owners.

To illustrate this result, we’re going to briefly examine a recent decision by the Federal Circuit, Ariosa v. Sequenom. In June of 2015, the Federal Circuit issued a ruling invalidating the method claims of U.S. Patent No. 6,258,540, held by Sequenom Inc. The patent concerned a means for using cell-free fetal DNA, which they discovered could be found in the blood of a pregnant mother, to determine the fetus’ susceptibility to a panel of genetic defects. The tests could also establish paternity or gender of the fetus, among other characteristics. While other diagnostic tests are able to make these determinations, until the method of the ‘540 patent was discovered the DNA for such tests would have to be harvested from the placenta or fetus. The method of the ‘540 patent allowed these tests to be run in a manner that was less invasive and dangerous for the fetus and the mother by using a sample of the mother’s blood. When the patent was struck down under the precedents set by Mayo and Alice, Sequenom petitioned the Federal Circuit for en banc review (a process by which the entire court is urged to reconsider the decision of one of its 3-judge panels). On December 2, 2015, the en banc court denied the petition, letting stand the panel’s decision and maintaining that it was bound by the Supreme Court decisions in Alice and Mayo.

Alice is firm on the impermissibility of patenting an abstract idea.

Ariosa represents one of the first major cases in which Alice and Mayo were applied to their fullest extent, with predictably troubling results. For instance, Alice is firm on the impermissibility of patenting an abstract idea (as is the language of 35 U.S.C. 101). However, the opinion issued by the Federal Circuit failed to define what constitutes an abstract idea, or offer a test for determining if an idea was too abstract to be patentable. Mayo concluded that discovering something new in nature did not show an inventive step; however, the court there stated that they “need not determine here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable”. Neither of these decisions made clear how their precedents should be applied in upcoming cases, yet both made clear that violations of these unknown standards would result in the invalidation of a patent.

Despite denying en banc review in the Sequenom case, the en banc review panel of judges expressed concerns about the rigid application of Alice and Mayo in these types of cases. Notably, Judge Dyk called the test of patentability outlined in Mayo “too restrictive" and stated that continued use of this standard may “discourage development and disclosure of new diagnostic and therapeutic methods in the life sciences.” He also noted that the discovery of natural laws is the basis of diagnostic methods, and further went on to say that an inventive concept is present in a novel discovery of “a specific application of [a] new law of nature discovered by the patent applicant and reduced to practice.”

While the denial of further review for Sequenom stands, opinions such as these issued by the Federal Circuit only serve to further highlight the need for clarification on what the Alice and Mayo decisions mean for those of us in the business of acquiring and enforcing patents. This certainly isn’t the end of what will be a difficult battle for patent owners in the fields of software and medical diagnostics. We’ll keep you posted on new developments on this topic as they emerge.